10
Nov
2004

Philips Medical Systems Class II

0

Company: Philips Medical Systems
Date of Enforcement Report: 11/10/04
Class: II

PRODUCT
Pagewriter Touch Cardiograph Software. Recall # Z-0063-05.

REASON
Software can generate printed ECG’s that associate incorrect patient data with the waveform.

CODE
Software Versions A.01.01 or A.01.02.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter on September 13, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
768 units.

DISTRIBUTION
Nationwide and Internationally.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

 

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